A. Sample submission requirements:
I. Essential Documents:
a. Forwarding Letter from Drug Regulatory Authority
or any other statutory authority of the country which has been marked to NIB
for testing/evaluation purpose.
b.
Copy
of Import License/Test License issued by Govt. of India
i. Form -11 (Copy of Import License for
Testing purpose)
ii. Form -10 (Copy of Import License for
Commercial purpose)
iii. MD-15 (Copy of License to Import Medical Device)
c.
Copy
of Manufacturing License Issued by Govt. of India (In case of Indigenous
Product) Form 25/28/29
d.
Certificate
of Analysis from Manufacturer in respect of the lot submitted for evaluation.
e. Batch
Release Certificate (BRC) from Manufacturer/NCA/NCL of the Country of origin
for the lot submitted for evaluation.
f. Three
List of Country, where the drug is marketed or regulatory status of the drug in
other countries.
g. Summary
of QC Protocols, Manufacturing Protocols from the manufacturer from country of
origin/product information /brochure/leaflet (in original) in English language.
h. Pack
insert and label Claim of the Product
II.
Product Specific requirements:
a) Blood
Products Lab- Plasma Based products:
1. Batch
Release from the country of origin
2. Plasma
pool certificated from NCL/manufacturer
3. Source
of Plasma
4. Period
of collection of plasma
5. Certificate
of compliance collection, processing storage and quality control of plasma as
per WHO
6. List
of countries product marketed
7. Method
of viral inactivation
8. Certification
of analysis with name of pharmacopoeia complied
b) Biochemical
kit lab (Glucose strips)
1. Type
of Sample: Blood Glucose Test strips designed for use with specific Glucometers
as a closed system that reports the human blood glucose values in mg/dL units.
2. Condition
of Packing: Blood Glucose Test Strips should be packed in properly labelled
sealed containers that give the details of the manufacturer and/ or the
importer and the Range of values reported by the strips for the Norma (Level
I) and the Pathological (Level II) Control preparations.
3. Number of Samples Essential: 2400 Test Strips
(1200 for the laboratory and 1200 as retained samples with the Sample Receipt
unit) for testing one Batch by the Laboratory.
4. Accessories
Required: 10 Glucometers designated for use with the Blood Glucose Test Strips
as a closed system.
5. 3ml
x 3 vials each of the manufacturers Normal/ Level I and Pathological/ Level II
Glucose control Solution for testing one batch of Blood Glucose Test Strips.
B.
Testing fee requirements:
Testing Fee Details
Payment
modes:
1. FOR PAYMENT/DEPOSIT
OF TESTING FEE THOUGH BANK TRANSFER
NAME
OF BANK : BANK OF BARODA, SECTOR-29, NOIDA
(U.P.)
NAME
OF ACCOUNT : NATIONAL INSTITUTE OF BIOLOGICALS
S.B.
ACCOUNT : 26290100001774
IFSC
CODE : BARB0NOIDAX
SWIFT
CODE : 2BARBINBBNOI
MICR
CODE NO. : 110012066
PAN -AAATN5228R
GSTIN -09AAATN5228R1ZX
ST No.-AAATN5228RST001
TIN -09466201769
2. Net banking : http://www.nib.gov.in/testing_fee.html
Note:
a)
TESTING
FEES IS REQUIRED TO BE SUBMITTED IN ADVANCE ALONG WITH THE RESPECTIVE BATCH
SENT TO THE INSTITUTE FOR TESTING
b) Testing
Fees once submitted at NIB for Samples forwarded through Zonal / Sub-zonal/
Port Offices of CDSCO which can be tested at NIB cannot be refunded.
c) Testing
Fees submitted at NIB for Samples which cannot be tested at NIB can be refunded
or adjusted against other samples within a month of submission of testing fee.
d) Testing
Fees submitted Online should also be intimated to the Institute through email
(1) srrd@nib.gov.in (2) sksharma@nib.gov.in
C. Sample forwarded under the Drugs & Cosmetics Act:
Govt. Analysts under schedule C1 as per the Gazette notification are notified
for the below mention class of drugs.
Govt_analyst.html
D. Documentation and Archiving:
All
documents and records are kept in compliance to ISO: 17025.
E.Complete Unit is under CCTV Surveillance
for necessary security and maintenance of samples and records.
F.Customer feedback is
always acknowledged. Submission of feedback should be marked at srrd@nib.gov.in. Further a
Suggestions / Complaints / Feedback Register has also being placed in the Unit for necessary redressal.
